Cleared Traditional

K926001 - MRT-50A

K926001 is the FDA 510(k) clearance for MRT-50A by Toshiba America Mri, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K926001 · Toshiba America Mri, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
315d
Days
Class 2
Risk

K926001 is an FDA 510(k) clearance for the MRT-50A, MRT-150A. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Toshiba America Mri, Inc. (S. San Francisco, US). The FDA issued a Cleared decision on October 8, 1993 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toshiba America Mri, Inc. devices

Submission Details

510(k) Number K926001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1992
Decision Date October 08, 1993
Days to Decision 315 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 107d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K926001.
ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY
K930960 · Toshiba America Mri, Inc. · Nov 1993
PHILIPS MRI BREAST COIL
K926275 · Philips Medical Systems, Inc. · Oct 1993
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K932344 · Siemens Medical Solutions USA, Inc. · Oct 1993
MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE
K925286 · Toshiba America Mri, Inc. · Oct 1993
GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0
K925985 · Elscint, Inc. · Oct 1993
MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15
K930779 · Medrad, Inc. · Oct 1993